PlainRecalls

Philips North America, LLC

Compiled from official public sources by the editorial team.

400 recalls on record · Latest: Feb 18, 2026

Philips North America, LLC Recall Insight

Philips North America, LLC appears on 400 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.393% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Dec 15, 2021 to Nov 22, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Nov 22, 2023

Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.

FDA Devices Moderate Nov 22, 2023

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and ther…

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Nov 15, 2023

DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.

FDA Devices Moderate Oct 11, 2023

EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380

FDA Devices Moderate Oct 11, 2023

EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 86…

FDA Devices Moderate Sep 27, 2023

Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number: 866389; (2) P…

FDA Devices Moderate Jul 5, 2023

DigitalDiagnost C90, Model No. 712034 and 712035

FDA Devices Moderate Jun 7, 2023

EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359

FDA Devices Moderate Jun 7, 2023

EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380

FDA Devices Moderate May 24, 2023

Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333

FDA Devices Moderate May 10, 2023

Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radiography and fluoroscopy (R/F) …

FDA Devices Moderate Apr 19, 2023

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

FDA Devices Moderate Apr 19, 2023

ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110

FDA Devices Moderate Apr 19, 2023

Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201

FDA Devices Moderate Apr 19, 2023

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Devices Moderate Jan 18, 2023

Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

FDA Devices Moderate Dec 14, 2022

Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144

FDA Devices Moderate Dec 14, 2022

Philips MR 7700 System, Model Number 782120

FDA Devices Moderate Dec 14, 2022

Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137

FDA Devices Moderate Dec 14, 2022

Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136

FDA Devices Moderate Dec 14, 2022

Philips Upgrade to MR 7700 System, Model Number 782130

FDA Devices Moderate Oct 12, 2022

MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

FDA Devices Moderate Sep 7, 2022

DigitalDiagnost C50 1.1

FDA Devices Moderate May 18, 2022

Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodyna…

FDA Devices Moderate Apr 20, 2022

The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, …

FDA Devices Moderate Apr 13, 2022

Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS

FDA Devices Moderate Apr 13, 2022

Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STERILE, Rx only…

FDA Devices Moderate Apr 13, 2022

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 7220…

FDA Devices Moderate Mar 16, 2022

Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip …

FDA Devices Moderate Mar 16, 2022

Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031

FDA Devices Moderate Feb 9, 2022

eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareMana…

FDA Devices Moderate Jan 26, 2022

Infa-Therm Transport Mattress, Reference Number 989805616831 1015

FDA Devices Moderate Jan 26, 2022

Medichoice Infant Heel Warmer, Reference # 989805643721 1079906

FDA Devices Moderate Jan 26, 2022

Heel Snuggler, Reference # 989805603411 99047

FDA Devices Moderate Jan 26, 2022

Infant Heel Warmers w/strap, Reference # 989805603201 1223

FDA Devices Moderate Jan 26, 2022

Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T

FDA Devices Moderate Jan 19, 2022

Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recover…

FDA Devices Moderate Jan 19, 2022

Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002,…

FDA Devices Moderate Dec 29, 2021

Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, incl…

FDA Devices Moderate Dec 15, 2021

BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

FDA Devices Moderate Dec 15, 2021

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.